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| Procedure Name | Registration for processing of veterinary drugs without certificates of free sale in Vietnam for export |
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| Description |
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Category
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Procedure for granting certification
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Responsible Agency
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Department of Animal Health - Ministry of Agriculture and Rural Development
Address: No. 15/78 Giai Phong Rd, Phuong Mai, Dong Da, Hanoi
Phone: 04.36290447
Email: Quanlythuoc@dah.gov.vn
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Legal base of the Procedure
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- Law on Veterinary Medicine 79/2015/QH13
- Decree 35/2016/ND-CP of the Government guiding the implementation of the Law on Veterinary Medicine
- Circular 13/2016/TT-BNNPTNT On veterinary drug management
- Circular 285/2016/TT-BTC On collection, payment, management and amount of veterinary fees and charges
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Processing time
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- Within ten (10) working days, inform the registering organization of the need for completion if the dossier is not complete;
- Within twenty (20) working days from the reception of the complete and valid dossier the Department of Animal Health shall examine the dossier and grant the Certificate of Free Sale
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Fee
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- Dossier examination: 1,153,000 VND/unit of product;
- Certificate granting: 70,000 VND/certificate
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Required Documents
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No.
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Type of documents
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Note
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1
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Written registration for processing for export
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2
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Summary of the products' properties
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3
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Sample product labels and user guide sheets
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4
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GMP Certificate of the processing establishment
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Original or notarized copy
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5
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Manufacturing process
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6
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Quality standards and testing methods
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7
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Certificate of Analyst (CA) of the processing establishment, Certificate of Analyst (CA) granted by the designated veterinary drug testing agency in Vietnam
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Original copy
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8
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A written commitment of processing for export and not for sale in Vietnam
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9
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A written commitment of non-violation of regulations of the law on intellectual property rights
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Annex XII Circular No. 13/2016/TT-BNNPTNT
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Process Steps
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Step 1
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The processing establishment shall submit the dossier of registration for processing of veterinary drugs to the Department of Animal Health
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Step 2
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Upon receiving the dossier of registration for processing, the Department of Animal Health shall inform the registering organization of the need for completion if the dossier is not complete;
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Step 3
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Upon receiving the complete and valid dossier, the Department of Animal Health shall examine the dossier and inform the registering organization of the result
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Step 4
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Grant the Certificate of Free Sale (CFS) if the dossier is satisfactory
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Process Map:
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| Category | Procedure |
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The following form/s are used in this procedure
This procedure applies to the following measures
